At a glance
ClinicalIndex Comparison Record- ✓Age 18-60 years, inclusive
- ✓BMI ≤35.0 kg/m²
- ✓Healthy with no prior SARS-CoV-2 exposure (RT-PCR negative and seronegative)
- ✓Screening labs normal: ALT, AST, glucose, bilirubin, BUN, creatinine within normal limits
- ✕Any prior investigational SARS-CoV-2 vaccine, monoclonal antibody, or convalescent plasma at any time
- ✕History of IgA deficiency
- ✕History of hemolytic anemia
- ✕Allergy or hypersensitivity to blood/plasma products or COVID-HIGIV excipients (proline, PS80)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) Administered as a Single Dose Regimen to Healthy Adults
In Brief
A Phase 1 clinical trial evaluating COVID-HIGIV and Placebo (saline) for COVID-19. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
Study Details
Timeline
Interventions
COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.